Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

OBJECTIVES:

Primary

- Compare the sensitivity and specificity of microsatellite analysis (MSA) of urine
sediment with cystoscopy and urine cytology for detecting bladder cancer in participants
undergoing cystoscopy.

Secondary

- Determine the temporal performance characteristics of MSA in urine sediment from these
participants.

- Determine which of the 15 individual markers or combination of markers that make up the
MSA test are most predictive of the presence of bladder cancer in these participants.

OUTLINE: This is a single-blind, multicenter, cohort study.

Urine and blood specimens are collected from all participants at baseline. Urine specimens
are examined using microsatellite analysis, urine cytology, and urinalysis. Patients in
groups 2 and 3 also undergo cystoscopy at baseline.

Patients in group 3 undergo cystoscopy, upper tract imaging (e.g., abdominal CT scan),
microsatellite analysis, urine cytology, and urinalysis every 3 months for 2 years in the
absence of progressive disease.

Microsatellite analysis, which identifies loss of heterozygosity using polymerase chain
reaction technique, is conducted for 15 markers: D4S243, D21S1245, FGA, D17S695, D16S476,
D9S171, IFN-A, D20S48, D13S802, D17S654, D16S310, THO1, D9S162, D9S747, and MBP.

PROJECTED ACCRUAL: A total of 500 participants (100 each for groups 1 and 2 and 300 for group
3) will be accrued for this study.

DISEASE CHARACTERISTICS:

- Group 1 (healthy volunteers):

- No prior or concurrent urologic disease or devices

- No genitourinary (GU) complaints, including urgency or frequency of urination

- Normal urinalysis and urine cytology

- Never smoked cigarettes regularly (i.e., ≥ 1 cigarette/day for ≥ 1 year)

- No suspected exposure to environmental bladder carcinogens for > 1 year,
including, but not limited to, the following occupations or exposures:

- Aluminum industry

- Aromatic amines

- Coal gasification

- Coal tars and pitches

- Coke plant

- Dye industry

- Leather industry

- Machinist

- Painter

- Rubber industry

- Truck, bus, or taxi drivers

- Group 2 (participants with condition(s) that lead to false-positive urinary bladder
cancer screening studies):

- GU complaints requiring cystoscopy

- No current GU malignancy

- At least 1 of the following conditions:

- Benign prostatic hypertrophy (International Prostate Symptom Score > 12)

- Foreign bodies (stones, stents, or catheters)

- Hematuria (gross or microscopic)

- GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis,
urethritis) within the past 3 months and completed treatment

- No sign of infection at the time of study participation

- Group 3 (superficial bladder cancer patients):

- Histologically confirmed superficial bladder urothelial malignancy

- Primary or recurrent disease

- No nontransitional cell carcinoma of the bladder, upper tract tumors,
muscle-invasive tumors, or superficial disease for which local therapy is not
appropriate

PATIENT CHARACTERISTICS:

Age

- Over 40

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- See Disease Characteristics

Other

- No prior cancer except nonmelanoma dermatologic malignancy

- Prior bladder cancer allowed for group 3 patients

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

- Prior intravesical therapy for bladder cancer allowed for group 3 patients

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- Not specified